Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury

Phase 1

• Conditions: Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter
• Interventions: Drug: Polyethylene Glycols

• Registration Number: NCT03236064
• Lead Sponsor: WellSpan Health

Brief Summary

This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.

Detailed Description

To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150 years much research has been performed. PEG-Axon fusion on the other hand is relatively new in mammals. Success has already been obtained by two institutions in the rat sciatic nerve transections, demonstrating rapid return of behavioral function4. These however are very controlled injuries and unclear how well these will translate into human studies. For this reason 3 separate clinical studies in increasing order of complexity are proposed.

The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-08-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-26
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nerve injury to palm and fingers	Polyethylene Glycols	Adult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited

Primary Outcome Measures

Name	Time	Method
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques	12 months	Three goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, rapid return of motor function and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure

Trial Locations

Locations (1)

WellSpanYork Hospital; 🇺🇸 York, Pennsylvania, United States